Reconsideration of a Patent Extension Term

In an odd development, but not one that without precedent – see here and here – Dr Shlomo Cohen Law Offices has asked the Israel Patent Office to reconsider a judicial ruling.

In this instance, the original ruling relates to the Patent Term Extension (PTE) of IL 169693 to “Bristol Myers Squibb” and Pfizer that issued under section 64(v)5 of the Israel Patent Law. The original ruling issued in September 2015, and granted a patent term extension of 974 days until 18 May 2025. That ruling followed a challenge by the patentees to Examiner’s decision of 5 March 2015.

The way that Patent Term Extensions (PTEs) are calculated in Israel is detailed in sections 64(ix) and 64(x) of the Israel Patent Law. The original ruling is based on section 64(x) which states that:

(1)…

(2) The combined period for the patent and the Patent Term Extension (PTE) for a formulation, a manufacturing process, for usage thereof and for medical preparations that include it, processes for manufacturing same and for medical equipment, for the original patent and for the Patent Term Extension (PTE) together should not terminate more than 14 years after the first marketing permission issued by one of the recognized jurisdictions.

In calculating the extension period that the Applicant in Israel is entitled to, the Examiner relied on the date that marketing was allowed in Italy as the date for calculating the 14 year period under Section 64(x)2 of the Law. It is noted in this regard that Italy is one of the ‘recognized jurisdictions’ that is listed in the First Appendix to the Law and on the basis of extension periods granted as “Order to Extend the Basic Patent” (as per 64a of the Israel Patent Law), the period of Extension was calculated.

The main claim of the Applicant that was considered in the original ruling was that when calculating the 14 year period of exclusivity under Section 64(x)2 of the Law in the light of marketing approval in Europe it is necessary to consider when the marketing approval actually issued in one of the recognized jurisdictions (in this instance Italy on 20 May 2011) and not the date when the ruling was given which was (two days earlier) on 18 May 2011. That claim was supported by an affidavit of the Patentee and on the date of publication of the ruling in the European Patent Journal.

To complete the picture it is noted that after the Israel Patent Office noted its intention to issue a Patent Term Extension (PTE) under section 64(v)1, the Applicant informed the Israel Patent Office that Germany had granted a 1341 day extension. That extension was from 18 September 2022 until 20 May 2026. Appended to the request was a translation of the German Patent Office to give a patent term extension there that was dated 20 May 2011.

In the claims discussed in the first decision the Applicant related to the question of determining when the then pending European marketing approval had issued, and at that time the question was pending a legal interpretation from the Court of justice of the European Union (CJEU). In the original ruling the Applicants claims against the Examiner were rejected and the Examiner’s decision was upheld. Subsequently, in 6 October 2015 the CJEU issued its ruling in C-471/14 Seattle Genetics vs. Österreichisches Patentamt:

“Article 13(1) of Regulation No 469/2009 is to be interpreted as meaning that the ‘date of the first authorisation to place the product on the market in the [European Union]’ within the meaning of that provision is the date on which notification of the decision granting marketing authorisation was given to the addressee of the decision“.

As the Applicant notes, after this decision of the CJEU and in light of it, the same consideration was applied to various other cases before the Israel Patent Office and the 14 year period was calculated from when the ruling was transmitted to the parties and not from the date published on the ruling as part of the ruling which is typically 2-3 days earlier. The Applicant considers this a general change in policy that should be retroactively applied in the present case, hence this request for reconsideration.

The Ruling

Commissioner Asa Kling writes as follows: As a primary matter it is noted that there is doubt as to whether there is room for reconsideration. Under the 1968 regulations and prior to the amendment of 21 October 2015 that entered into force 60 days later, the period for appealing the original ruling was until 16 November 2015, one month after the CJEU ruling issued. In other words, to the extent that the Applicant considered that the European ruling justified reconsideration in Israel; the issue should have been raised in a timely manner, and before the appeal period passed. This request for reconsideration was filed some six months after the CJEU ruling issued and is thus tardy.

It is noted that during the interim six months the intention to issue a patent term extension was published and the period of opposition had passed. In previous rulings concerning IL 127115, IL 130492, IL 159512 and IL 132304 to Immunex Corporation et al. of 7 September 2014, and in light of the wording of Section 63(vii)(b) of the Law, once the opposition period has passed the grounds for opposition are limited and the public is entitled to a degree of certainty regarding intentions that have published.

As a general rule reconsideration of a decision will be permitted only in rare cases. As ruled in Appeal 8347/08 Kashi vs. Moshe Kasha Building Contractors’ Company ltd. 699 (29) 2009:

“Usage of the reconsideration proceeding is limited to rare events where a court examines an interim ruling again; typically in the light of new developments and revelations (Appeal 3604/02 Oko vs. Shemi, P.D. 56(5) 505 (2002). This proceeding cannot serve as a means for appealing a final ruling that establishes a court decision. As no appeal against the ruling was filed in a timely manner, it becomes inviolate. One cannot artificially extend the appeal period by means of a reconsideration proceedings.

It has also been ruled that a reconsideration proceeding is not for the purpose of raising issues that should properly be raised in an Appeal. Thus for example Supreme Court Appeal 1574/11 “Strauss marketing Ltd vs. Moshe Orman (Nevo 14 July 2011) section 13 states:

“As a general rule, the correct way to challenge a court ruling is not to request reconsideration unless there is a change of circumstances that warrants reconsideration”.

Submissions that are appeal-like in nature should not be addressed to the same court. That said, a court may reconsider and change in its ruling in rare cases that it concludes that it has made a mistake.

According to the Applicant, the original decision is an administrative decision that they believe has other rules for reconsideration. Changes in administrative rulings were discussed at length in Bagatz 5368/96 MK Pinchasi vs. Legal Counsel to the Government (24 October 1996) Section 13 of decision, by then President Aharon Barak:

It is a matter of law that an authority that makes a decision is entitled to deviate from that decision (see Section 15 of the Law of Interpretation 1981) or to reconsider a ruling (see Section 11 of the Law of Interpretation). This is required to further general aims such as peace, profit and security of the public), and also to attain specific aims for that authorized.

With this, the authorization to change or reconsider is not unlimited. There are values and principles that all authorities should take into account, that negate reconsideration and further finality of rulings. Central to these are stability and certainty, actualization of reasonable anticipations and the like and considerations that are tied to the rights of individuals that relied on the administrative ruling in question. These considerations promote the interest of finality of decisions. Thus the question of whether reconsideration is appropriate is one of balance between the desire for finality in rulings and the need for rulings to reflect the public interest. See Bagatz 189/78 Asadi vs. The Committee of Appeals concerning Taxis and Others [9] on page 647.

…

It is stressed that a change in a decision is possible “if a reevaluation of the facts is appropriate and failure to reevaluate will damage the public good or security, and the only reason not to reconsider is one of ossification of public decisions’…

It is true that the position of the CJEU was adopted by the Patent Office in certain cases. These cases are those that were pending before the patent office and had not yet been ruled on.

Calculation of the Patent Term Extension period in those cases where it was calculated based on the time of providing the patentee with the decision happened in specific cases based on evidence provided to the Israel Patent Office. It is doubtful whether one can deduce a sweeping change of policy of the Israel Patent Office, and it is even more doubtful that there is a change of policy that is retroactively applicable. It is also stressed that in the present request for reconsideration it was not stated that in Italy the Extension period was reconsidered, and this was the basis of the Patent Term Extension period granted in Israel.

The Commissioner does not think that from a limited number of specific cases one can fairly deduce the conclusion that the patentees desire to deduce. Thus even if one agrees that further consideration is warranted, it is not clear that such further consideration would achieve the outcome desired by the patentees. There is no justification for selective reconsideration (See Appeal 3604/13 Tax Authority vs. Yigal Zvi Eisinger, Nevo 10 May 2015) paragraph 14, Judge Mazoz.

The Applicant alleges having discerned a sweeping change of policy. Even if this was the case, applying a change in policy retroactively should be undertaken very carefully. Although in Eisinger the Supreme Court concluded that administrative-government decisions are never final (see paragraphs 14-18), the Supreme Court stressed the differences between reexamination of general principles and reconsideration specific individual cases.

Reconsideration of general principles is different from reconsideration of specific cases. As a rule one can state that the legislative and administrative authorities have wide discretion to change decisions having general effect such as legislation and policy and the earlier decision is not binding. However, with regards to individual rulings, the authorities have less freedom to operate and must consider the common good in all suggested changes as well as the specific and legitimate interests of the parties affected by the issue (paragraph 21 of Eisinger).

The above was stated in cases where the individual would be hurt by the change or cancellation of the ruling. This is also relevant where one party will benefit but other parties will lose by the change. The original decision has already published and other parties may have relied on the decision. From this it is clear that the Patent Office has limited discretion to reconsider decisions. This is clearly the case where reconsideration based on a decision of a foreign court (the CJEU) is invoked to attempt to justify a retroactive change of policy. In this instance there are no grounds for this.

The question of retroactive application of changes in policy on Patent Term Extensions was actually considered in the Patent Term Extension for IL 97612 to Sanofi Synthelabo (27 May 2005). As ruled in that decision, changes in the extension period will benefit some and be to the detriment of others. Furthermore, as the Supreme Court recently ruled in 8127/15, Israel Industrialists vs. Merck Sharp & Dohme 15 June 2016, paragraph 12 as far as Patent Term Extensions are concerned, “Balancing the different interests is a delicate task…”. In this instance, the Applicant has not provided any justifications for retroactively granting them a two-day extension.

In Bagatz 1398/07 Dr Lavie-Goldstein vs. Ministry of Education – the Body for Foreign Degrees (10 May 2010) it was determined that as a general rule the Administrative Authorities are allowed at any time and sometimes are obliged to change their policies due to changes of circumstances. However, despite this, the Supreme Court stated (paragraph 22):

When deciding on a change of policy, the authority has to consider the ‘time dimension’ as Judge Zamir called it in Bagatz 2832/96 Banai vs. the Israel Bar, p.d. 50(2) 582, 592693 (1996). With respect to this dimension it is necessary to decide if the change is retroactive, is immediately applicable or if it is to come into effect from a future date, such as where those relying on the change require time to adjust to them. In these matters, the modern approach is to only rarely apply rulings retroactively and to even be careful of immediate effect. See Professor Dafna Barak-Erez’ new book: Administrative Law Vol 1 366-269 (2010). As a general rule, changes in policy should be forward-looking and not backwards-looking See Bagatz 134/67 Vanunu vs. Ministry of Transport p.d. 21(2) 710, 716-717 (1967); Bagatz Scitex Ltd vs. the Minister of Trade and Industry p.d. 30(1) 672, 676 (1975).

In light of the above, the Commissioner sees no room for reconsideration even if there has been a change of policy. Furthermore, even were the Patent Office to reconsider their decision, the German ruling changes nothing since the Israel Extension is based on the shortest extension of any country granting extensions, and this remains the Italian extension. The request for reconsideration is denied.

Retroactive patent legislation is sometimes the better of the various evils. With the best of intentions, then Commissioner Dr Meir Noam decided to stop wasting paper and publishing hard copies of the Israel Patent Office Journal as the information contained therein was available on-line via the patent office website. The Knesset Committee headed by the Late David Rotem MK, noted that this was ultra-vires and that applicants had paid a publication fee. In an announcement of December 2010, the publication fees were supposed to be refunded. Then someone had a bright idea and an amendment to the Israel Patent Law 1967 dated 12 January 2011, came into effect retroactively from 1 January 2007, that the first publication of biographical details, name of Applicant, title of application, priority and filing date for new patent filings is to be performed on the Internet and not in the Official (printed) Patent Office Gazette – see here. Clearly this type of thing is best done in exceptional circumstances only.

Through reading and reporting on patent office decisions I do sometimes discern changes of policy. I think that there has been one regarding missed PCT deadlines and other cases where the Law calls for due care. This used to require an act of God but since Reinhold Cohn missed the deadline for filing a request for patent term extension in IL 154325 to Centocor Ortho Biotech Inc where the Law itself requires unavoidable circumstances, things seem to have become more flexible. That said, I think reinstatement of lapsed patents has become more difficult. Senior staff at the Israel Patent Office changes over time. There are binding court rulings to consider and the changing world with ever-increasing computerization, greater access to information and the like makes changes in policy inevitable. Sometimes, as with the patentability of software inventions, despite clarification, it is sometimes difficult to understand what the policy actually is.

It was tempting to request reconsideration of old decisions in light of layer ones but it seemed clear to me that the Patent Office would not look favorably on such shenanigans. There are arguably inconsistencies in decisions and one cannot put everything down to a change of policy. Of course in a recent decision IL 110956 for Ezetimibe Judge Hendel of the Supreme Court actually explained Israel policy with regards to patent term extensions. It can be stated as follows: Patent term extensions are an attempt at market regulation. Israel protects local generic players by granting the shortest extension granted by any country granting an extension so that the additional exclusivity period is as short as possible. Although that ruling is not surprising (at least not to me) it is noted that the present request for reconsideration was filed before the Supreme Court ruling.

Back in 2011, Aharon Factor representing the Opposers prevailed in an interim skirmish against Shlomo Cohen Law Offices who asked for reconsideration of a decision. See here.